Post Surgical Multimodal Analgesia With Oral Strong Opioids
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTri-Service General Hospital
About this trial
This is a prospective observational case study, focusing on the clinical effectiveness of oral strong opioids for pain management following common orthopedic surgeries.The study aims to evaluate the effectiveness of multimodal analgesia with oral strong opioids, reduce common opioid-related side effects, and improve patient compliance and satisfaction.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18 or older
Disqualifiers
Patients who have not received any or have only received oral potent opioids for no more than 1 day during the postoperative hospitalization period (including those known to be intolerant or allergic to opioid medications).
Patients who have received or are expected to use long-acting opioid injections within 7 days before surgery or during the postoperative hospitalization period.
Patients who use patient-controlled analgesics for pain control after surgery.
Patients with a history of substance abuse or who require continuous treatment with other opioid receptor agonists or antagonists (such as naloxone or methadone).
Trial population
Patients who are hospitalized for the following surgical treatment may be enrolled: 1. Fracture of upper or lower limbs or pelvis requiring internal fixation surgery 2. Spinal fusion surgery 3. Joint replacement surgery
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Multimodal analgesia with oral strong opioids
DrugPhysician's choice of post-surgical multimodal analgesia with an oral strong opioid as the backbone analgesics
Treatment groups
200 Participants
are divided into 3 treatment groupsGroup A: Fracture fixation1 intervention
Group B: Spinal fusion1 intervention
Group C: Arthroplasty1 intervention
Trial outcomes
Primary outcomes
1
Change in pain scores from baseline
Assess the efficacy of including oral strong opioids in multimodal pain control. For this objective, we will observe changes in pain scores among participants during postoperative treatment.
Time frame
Twice daily during hospitalization (approximately within 1 week), at the first return 1 day visit and at 3 months after surgerySecondary outcomes
1
Occurence of adverse events
Avoid common adverse reactions associated with traditional morphine-like drugs, such as respiratory depression and addiction, to enhance treatment safety and patient comfort. We will monitor the occurrence rate of adverse reactions related to oral potent opioids.
Time frame
During hospitalization (approximately within 1 week)2
Compliance of oral strong opioids
Improvement the convenience of analgesic medication by transitioning from injections to oral administration, making it easier for patients to accept and adhere to the treatment plan. The compliance rate of oral strong opioids will be measured.
Time frame
During hospitalization (approximately within 1 week)3
Physician's global impression - improvement scale(CGI-I)
Effectiveness of the pain control will be assessed by a 7-point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. Scale 1= Very much improved and scale 7 = very much worse
Time frame
During hospitalization (approximately within 1 week), at the first return 1 day visit and at 3 months after surgery4
Satisfation of the pain control as per patients' report outcome
Enhance patient acceptance of the treatment by using oral administration, boosting confidence in the treatment plan and increasing adherence and effectiveness. Patient satisfaction and pain improvement will be assessed through a 5-point scale questionnaire. 1=very much discontent, 2=discontent, 3=fair, 4=satisfied, 5=very much satisfied.
Time frame
End of hospitalization (approximately 1 week after surgery)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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